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United States · US · US:85534-0004_37457bd5-2fd0-b829-e063-6294a90a04f0
BACLOFEN
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHAWAII REPACK, INC.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc118553400040100 TABLET in 1 BOTTLE (85534-0004-0)
- ndc118553400041120 TABLET in 1 BOTTLE (85534-0004-1)
- ndc11855340004330 TABLET in 1 BOTTLE (85534-0004-3)
- ndc11855340004660 TABLET in 1 BOTTLE (85534-0004-6)
- ndc11855340004990 TABLET in 1 BOTTLE (85534-0004-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A214099
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "H789N3FKE8",
"rxcui": "1292",
"inchikey": "KPYSYYIEGFHWSV-UHFFFAOYSA-N",
"display_name": "BACLOFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e017a001-8cb1-4dd8-960e-c6d74005f57f": {
"match": "brand_token",
"title": "BACLOFEN TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "85534-0004_37457bd5-2fd0-b829-e063-6294a90a04f0",
"productndc": "85534-0004",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214099",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 13, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Jul 13, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Nov 21, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214099",
"marketing_category": "ANDA",
"nonproprietary_name": "BACLOFEN",
"start_marketing_date": "20210713",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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